Job Details

OrganaBio was founded in 2018 with the mission to become the hub for tissue sourcing, clinical sample processing and contract manufacturing services to support cell and gene therapy developers around the globe. At our core, we continually apply a data-driven approach with meaningful insights across our strategically located facilities to provide solutions to our clients where they need it most. Headquartered in Miami, Florida, OrganaBio delivers products and services that span the full development lifecycle from proprietary tissue supply chains and cellular starting materials to expert development, testing, and other support services that expedite the path to clinical translation.

Overview

A Cell Processing Associate assists in the performance of primary peripheral blood mononuclear cells (PBMCs) isolation from patient samples, as part of screening efforts for various customers. This position will help contribute to PBMC isolation process improvement, to drive efficiency in the documentation and production process. This role will support Process Development (PD) team efforts, and interact cross-functionally with teams that include, but are not limited to Business Development and Quality Assurance, to ensure company milestones are met. This position will ensure that products are processed under GLP practices, with appropriate documentation in place, it will also interact with external customers for which samples are processed, assuring that such communication is clear and disseminated in time, and processed samples are shipped back to customer, according to customer timeline.

Description

The Employee is hired as an on-call hourly employee and will not have guaranteed scheduled hours.

The Employer will provide the Employee with at least 24 hours notice for on-call shifts when possible.

The Employee must respond to on-call requests within 30 minutes of being contacted (within working business hours).

Essential Functions

• Routinely assist in the performance of PBMC isolation whole blood samples sent to OrganaBio for processing.
• Contribute to completing all the applicable paperwork provided by individual customers and developing adequate documentation for customers where such documentation is missing.
• Effectively communicate with customer for which samples are processed.
• Follow established PBMC isolation methods.
• Understand and interpret research protocols, established scope of work (SOW) documents and applicable Standard Operating Procedures (SOPs). Participate in the development of new/revision of existing documents.
• Record laboratory data in the applicable data management system(s) and paper-based document systems and contribute to technical customer-centered reports.
• Communicate with cross-functional teams to include Quality Assurance and Business development, as needed.
• Provide regular production status updates to PD & BD team leadership / project management teams.
• Support daily laboratory operations, including cleaning, maintenance, ordering, and inventory management
• Assist with kitting for routine GMP & RUO manufacturing activities
• Contribute to the development of new, custom, and/or existing products according to established Project timelines

Non-Essential Functions

• Assure there is sufficient materials and supplies inventory for scheduling product processing.
• Assist with equipment maintenance and preventative maintenance routines when it becomes necessary.
• Participate in mandatory training activities and maintain an acceptable level of knowledge and competency required to perform essential functions listed above. Have all training activities documented, as required by applicable regulations and standards, in timely manner.
• Other duties as assigned

Position Qualifications

Competencies

• Excellent oral and written communication skills
• Attention to detail and careful record-keeping
• Excellent organizational skills and ability to manage multiple projects
• Ability to work independently and collaboratively in a fast-paced, dynamic environment
• Productive, solution-oriented work ethic
• Flexible Mindset
• Maintain honesty, integrity, and an excellent work ethic
• Excellent interpersonal, organizational, communication and listening skills.

Skills and Abilities

• Education: Bachelor or Associate Degree in Biology, Cell and Molecular Biology, Biotechnology, Biomedical Engineering, or related field.
• Experience: 1-2 years of experience in laboratory work, basic laboratory techniques, aseptic technique and final fill and finish.
• Computer Skills: Proficient in Microsoft Office products.
• Certificates & Licenses: NA, Lab Technologist license is an asset

Other Requirements

• Familiarity with aseptic technique and PBMC isolation
• Foundational knowledge of GLP, GMP, and GDP regulations.
• Knowledge of appropriate personal protective equipment (PPE) for the handling of potentially infectious materials, sharps, and biomedical waste.